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The Effects of Limb Elevation During Gout Flare Episodes

The Effects of Limb Elevation During Gout Flare Episodes : A Pilot, Randomised Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06207045
Enrollment
30
Registered
2024-01-16
Start date
2024-02-01
Completion date
2024-10-31
Last updated
2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout Flare

Keywords

Gout, arthritis, gout flare

Brief summary

The goal of this open-label randomized controlled trial is to explore the benefit of limb elevation in inpatient gout flare episodes, compared with standard treatment The main questions are; * Is limb elevation able to reduce pain during gout flare episodes to a greater degree compared with standard treatment ? * Is Is limb elevation able to reduce joint swelling during gout flare episodes to a greater degree compared with standard treatment ? Participants will be divided into 2 group; 1. Limb elevation group 2. control group All participants will receive standard medical therapy consisting of colchicine 0.6 mg per day plus prednisolone 30 mg per day for 2 days Pain score and joint circumference will be recored at recruitment, 24 hour and 48 hour

Detailed description

Limb elevation has shown benefit in ankle sprain and venous insufficiency, but its benefit has not been studied in people with gout flare. In this open-label randomized controlled trial, 30 adults diagnosed with gout flare during their hospitalization will be randomized to receive limb elevation plus standard medication for gout flare (limb elevation group) or standard medication only (control group). Primary outcome is reduction in 10-point visual analogue scale for pain at 48 hours after enrollment and the secondary outcome is the reduction of the circumference of affected joint at 48 hours after enrollment. Comparison of pain score and joint circumference reduction will be made using Wilcoxon Rank-sum test. Our study results may provide some evidence in support of limb elevation as a supplementary non-pharmacological therapy for relief of gout flare.

Interventions

PROCEDURElimb elevation

limb elevation more than 45 degrees

Sponsors

Thammasat University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged ≥ 18 years * Diagnosis of Gout according to 2015 The ACR/EULAR gout classification criteria

Exclusion criteria

* Receive Non-Steroidal Anti-inflammatory Drugs or Intra-articular corticosteroids or prednisolone \> 10 mg within 24 hours before enrollment * Unstable vital sign * Receiving joint aspiration for release joint effusion ≥ 10 ml after enrollment * Gout flares involve axial joints e.g. hip * Glomerular Filtration Rates \< 30 ml/min/1.73m2 * Communication problems

Design outcomes

Primary

MeasureTime frameDescription
Reduction of pain score48 hours10-points Visual Analogue Scale

Secondary

MeasureTime frameDescription
Joint circumference48 hourscircumference of affected joint in centimeter

Countries

Thailand

Contacts

Primary ContactRatchayaSaitip Lertnawapan
ratchas@yahoo.com0973941619
Backup Contactkanon jatuworapruk
kanon@tu.ac.th029269794

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026